Observational Prospective Study on Resective and Regenerative Periodontal Therapy: Short & Longterm Follow-up

NCT07283393 | Active Not Recruiting

• 1 other identifier: ONZ-2023-0622
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Periodontitis is a common inflammatory disease affecting approximately 40% of the Belgian population. The goal of this observational study is to learn about the treatment outcomes of surgical periodontal therapy in adults with periodontitis. The main questions this study aims to answer are:

• Does subsequent surgical intervention further improve periodontal health parameters?
• Is there any significant difference between treatment outcomes of resective and regenerative periodontal surgery. Participants will: \- Undergo surgical periodontal treatment if residual pocket depth ≥6 mm persists despite good oral hygiene. Study inclusion was performed after surgical treatment. \- Be screened on various intervals. If there is any recurrent periodontitis, adequate treatment will be performed In short term, pocket probing depth is our primary outcome and tooth survival is the outcome in the long term. Secondary outcomes in short-term are bone level, mobility, bleeding on probing, tooth survival and cost-effectiveness. Long-term outcomes (\>5 years) are probing pocket depth, bone level, tooth sensitivity, mobility, bleeding on probing and cost-effectiveness.

Conditions

Periodontal Diseases; Periodontitis

Outcome Measures

Primary Outcomes (2)

• Probing depth

  Probing depth evolution in the short term

  At 6 months, 1 year, 3 years, 5 years, 7 years and 10 years of follow-up

• Tooth retention

  Survival of tooth in the long-term follow-up

  From enrollment to the end of the study, at 10 years of follow up

Secondary Outcomes (3)

• Radiographic bone level

  6 months, 3 years, 5 years, 7 years and 10 years

• Tooth mobility

  At 6 months, 1 year, 3 years, 5, 7 and 10 years of follow-up.

• Bleeding on probing

  At 6 months, 1 year, 3 years, 5, 7 and 10 years of follow-up

Study Arms (1)

Periodontitis patients actively treated with regenerative or resective surgery.

Periodontitis patients actively treated with regenerative or resective surgery. The study commences only after the patient has undergone either a regenerative or resective periodontal surgery; the surgical procedure itself is not part of the investigation. The objective of the study is to monitor and compare both treatment modalities in the short and long term with respect to tooth survival, bone level, probing pocket depth, tooth sensitivity, mobility, bleeding on probing, and cost-effectiveness. The dental patient records will be reviewed to obtain available data from before and during the surgical procedure, including general patient information (age, sex, ASA classification, and medication), periodontal status, radiographic documentation, and clinical photographs.

Diagnostic Test: Periodontal charting, peri-apical radiograph and low-dose small-field cone beam CT

Interventions

Periodontal charting, peri-apical radiograph and low-dose small-field cone beam CT DIAGNOSTIC_TEST

Clinical measurements through periodontal charting, peri-apical radiography and cone-beam computed tomography. Clinical pictures of the mouth

Periodontitis patients actively treated with regenerative or resective surgery.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients aged at least 18 years old have been treated for periodontitis through subgingival debridement. During re-evaluation, remaining pockets were found despite adequate oral hygiene. Depending on the anatomy of the defect, resective or regenerative surgery was performed. Patients were included if resective or regenerative periodontal surgery was performed \< 6months ago and an informed consent was signed.

You may qualify if:

• Min 18 years of age
• Max 6 months since resective or regenerative periodontal surgery
• Good general health

You may not qualify if:

• Pregnancy and breastfeeding

Sponsors & Collaborators

• University Hospital, Ghent: lead
• University Ghent: collaborator

Study Sites (1)

Ghent University Hospital

Ghent, East-Flanders, 9000, Belgium

Location

MeSH Terms

Conditions

Periodontal Diseases; Periodontitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2025
• First Posted: December 15, 2025
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2034
• Study Completion (Estimated): December 31, 2035
• Last Updated: December 15, 2025

Record last verified: 2025-12

Locations

BE (1)